Field of the Invention and Description of the Prior Art
This invention relates to textured softgels (or soft gelatin capsules) and to a process and apparatus for the manufacture thereof.
Soft gelatin capsules, now more commonly known as softgels, have been well known and widely used for many years. Softgels generally comprise an outer shell primarily made of gelatin, a plasticizer, and water, and a fill contained within the shell. The fill may be selected from any of a wide variety of substances that are compatible with the gelatin shell. Softgels are widely used in the pharmaceutical industry as an oral dosage form containing many different types of pharmaceutical and vitamin products. In addition to use as an oral dosage form for drugs and vitamins, soft gelatin capsules or softgels are also designed for use as suppositories for rectal or vaginal use. Other uses are for topical and ophthalmic preparations and the like. The cosmetic industry also uses softgels as a specialized package for various types of perfumes, oils, shampoos, skin creams and the like. Softgels are available in a great variety of sizes and shapes, including round shapes, oval shapes, oblong shapes, tube shapes and other special types of shapes such as stars. The finished capsules or softgels can be made in a variety of colors. Also, opacifiers may be added to the shell.
Although softgels can be made in a wide variety of shapes, sizes and colors, because of the wide range of use of softgels, there is a definite need to provide other means of identification. In this regard, it is quite common today to have an indicia of some type printed on each softgel after formation. The printing material may be any suitable dye or pigment. In some equipment, this has the disadvantage of requiring the use of an additional machine that will align the softgels and hold them in a desired oriented position for the application of the dye or ink. The use of additional equipment and procedural steps adds to the overall cost of manufacture of the softgels and, therefore, this system is considered disadvantageous. Also, the printing of each softgel can be done over only a limited portion of the exterior surface of the softgel and may not be readily read or even seen by the consumer. Specific examples of known processes and machines used for applying some type of identification on the softgels are those shown, for example, in Power (Posner) U.S. Pat. No. 2,449,139; Scherer U.S. Pat. No. 2,623,494; Scherer U.S. Pat. No. 2,703,047; Scherer U.S. Pat. No. 2,688,775; Taylor U.S. Pat. No. 3,124,840; Hansen U.S. Pat. No. 3,203,347; and Vincent U.S. Pat. No. 3,333,031.
The Posner Patent shows gelatin as one possible type of system that can be used in connection with an apparatus for manufacturing and filling capsules. In this patent, as seen best in FIG. 9 thereof, a tube of gelatin is formed and then a textured brand is applied to a portion of the outer surface of the tube. The capsule is then filled and sealed. This apparatus is used in quite a different system from the rotary die process which is probably the most common type of machine used for manufacturing softgels today. The rotary die process is described in some detail in Stanley's Chapter 13 of Lachman, Lieberman, and Kanig, The Theory and Practice of Industrial Chemistry (Copyright Lea & Febiger, 1970). In the rotary die process for manufacturing softgels, two gelatin ribbons are prepared, fed simultaneously to the fill area, and simultaneously and continuously filled, formed, hermetically sealed, and automatically cut between two rotary dies. The disclosure in the article by Stanley, as identified above, is incorporated into this specification by reference as being quite fully descriptive of the rotary die process, with which the present invention is involved, as opposed to the process disclosed in the Power patent.
The Scherer U.S. Pat. No. 2,623,494 relates to a banding machine for softgels. In this machine, the identifying band is applied to each individual capsule after the capsule is formed.
The Scherer U.S. Pat. No. 2,688,775 shows a method for applying a brand to the exterior surface of a gelatin capsule.
The Scherer U.S. Pat. No. 2,703,047 discloses a similar system of branding the filled capsules.
In the Taylor U.S. Pat. No. 3,124,840, a printing element is provided in order to print on the gelatin strip prior to the formation of the capsule.
The Hansen U.S. Pat. No. 3,203,347 shows a marking fluid that is printed on the gelatin ribbon used to make the softgels.
The Vincent U.S. Pat. No. 3,333,031 shows dying of the gelatin strip before capsule formation.
Even though efforts have been made to manufacture gelatin capsule and distinguish them from those of others by using different shapes, sizes, colors, color combinations, branding, banding, and printing, there still is a need to provide a way to even more uniquely identify one company's product from that of another while accomplishing this in a very unique, economical, and simplified manner.